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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pulmonary hypertension machine learning-based notification software
Definition Pulmonary hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of pulmonary hypertension for further referral or diagnostic follow-up.
Product CodeSAT
Regulation Number 870.2380
Device Class 2


Premarket Reviews
ManufacturerDecision
ANALYTICS FOR LIFE, INC.
  SUBSTANTIALLY EQUIVALENT 1

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